Ark. officials: Death after brain-eating amoeba infection likely exposed at splash pad

 An Arkansas resident has died after being infected with an extremely rare brain-eating amoeba and health officials have concluded they were likely exposed to it at a country’s club’s splash pad, authorities announced Thursday.

The Arkansas Department of Health announced the death from the Naegleria fowleri infection, a rare infection which destroys brain tissue, causing brain swelling and in certain cases, death. The department did not release details on the age of the person who died. The department said there is no ongoing risk to the public from the exposure.

The department said it concluded that the person who died was likely exposed at the Country Club of Little Rock’s splash pad. The department said it sent multiple samples from the country’s club pool and splash pad to the Centers for Disease Control and Prevention. The CDC confirmed one splash pad sample had viable Naegleria fowleri, the department said.

The country club has voluntarily closed the pool and splash pad, the department said. The pool and splash pad remain closed. The department said it has been in contact with the country club, which it said has been cooperative with inquiries.

Naegleria fowleri infects people when water containing the ameba enters the body through the nose, according to the CDC. This typically happens when people go swimming, diving, or when they put their heads under fresh water, like in lakes and rivers. The department said it is important to maintain pools and splash pads by making sure that disinfection levels are appropriate and free of soil contamination.

People cannot be infected with Naegleria fowleri by drinking contaminated water, according to the CDC. The last case reported in Arkansas was in 2013. Only about three people in the United States get infected each year, but these infections are usually fatal.

https://apnews.com/article/braineating-amoeba-arkansas-country-club-6b351e1bf6386247fadd2c981aedce26

Stroke Doesn't Have to Lead to Death or Disability

 Imagine having a severe, life-threatening stroke at 5 p.m., being rushed by ambulance to undergo minimally invasive surgery to remove the blood clot from your brain, then walking out of the hospital, symptom-free, the very next morning. That's what happened to 72-year-old Carleton Golder.

It's widely assumed that the outcome of a stroke will be one of three options: death, life-long disability, or a long, grueling recovery. As it stands, stroke is the fifth most common cause of death in America and a leading cause of adult disability. It reduces mobility in more than halfopens in a new tab or window of stroke survivors ages 65 and older. While these outcomes can't be completely eliminated, Golder's experience can be far more common.

When treated quickly and appropriately, even people with the most severe strokes can survive and thrive. The problem is that most stroke patients aren't accessing the treatment they need, particularly those who are most vulnerable. This is especially true for those patients who first are taken to a lower level center and then need to be subsequently transferred to a higher level hospital for specialized treatment. According to new JAMA study

opens in a new tab or window, stroke patients who are female, Black, Hispanic, or 80-plus years of age have a significantly longer delay for inter-hospital transfers. This is unacceptable and demonstrates that the system -- even with significant improvements in some regions -- is still failing too many people.

Field triage protocols where emergency services personnel assess stroke severity in the field and then, depending on the case, have the option to take patients to the most appropriate center rather than the closest should be standard practice everywhere. This can help close the gap in systemic disparities in care.

Medicine has delivered a groundbreaking treatment for the most dangerous strokes, known as emergent large vessel occlusions. During a mechanical thrombectomy, neurointerventionalists, physicians with dedicated expertise in minimally invasive procedures in the brain, use catheters to quickly reopen blocked arteries in the brain -- in as quickly as 20 minutes in some cases. This is a safe and well-established procedure, and has been the standard of care since 2015. However, less than one-third

opens in a new tab or window of stroke patients who are eligible receive this life-saving procedure. For most, it comes down to getting to the appropriate medical facility in time to receive treatment. This is where EMS comes in.

Over the past 7 years, physicians, patients, and advocates have pushed forward changes to EMS triage and transport protocols across the country. To date, 41 statesopens in a new tab or window have updated local or statewide stroke system policies (such as ensuring severe stroke patients are transported to a Level 1 stroke center), with others poised to make similar changes. The challenge now is to motivate stroke patients or family members to call 911 at any sign of stroke so that they can plug into these improved systems.

Research shows stroke patients and their families hesitate

opens in a new tab or window to call 911 for a variety of reasons, such as failing to realize the emergency nature of the situation, wanting to go to a specific hospital, worrying about transport costs, or lacking understanding about the speed and efficacy of being taken in an ambulance.

But the fact is when a person calls 911 for stroke, first responders can assess their condition and start treatment right away. Driving to the emergency department (ED) and waiting in line puts a patient at risk of not recovering. Not only that, the newly updated triage and transport protocols ensure that most patients who call 911 will be taken directly to a facility that is best equipped to treat them.

This unaccessed care is costing us on an individual and societal level. Stroke costs in the U.S. are approximately $56.5 billion. Additionally, for every minute saved in transfer to the appropriate care, there is $1,000 in savingsopens in a new tab or window on medical costs for short- and long-term care. So, patients who hesitate to call an ambulance due to the anticipated expense might be costing themselves thousands more in costs related to recovery and lost wages.

Updating triage and transport protocols nationwide was the first step in ensuring patients survive and thrive after a severe stroke. Now healthcare providers, patient advocates, and community leaders all have a role to play in getting people to call 911. Promoting simple tools like BEFAST (balance, eyes, facial drooping, arm weakness, slurred speech, time to go to the ED) can help patients understand the signs and take them seriously.

Golder says he owes his life to the young man that called 911 for him. Golder was conducting a job interview when the applicant noticed that he was rubbing his temples, and at one point "got lost" in the discussion. The applicant recognized the signs of a stroke and immediately called 911. Within 8 minutes, EMS was on the scene.

No one is immune to stroke, but everyone should have access to the best possible stroke care when they need it, no matter where they live. Because when it comes to stroke, calling 911 is essential. The medical system should take care of the rest.

Mahesh Jayaraman, MD,opens in a new tab or window is an interventional neuroradiologist at Rhode Island Hospital and the president of the Society of opens in a new tab or windowNeuroInterventional Surgeryopens in a new tab or window.

https://www.medpagetoday.com/opinion/second-opinions/106356

Facebook Efforts to Stymie Antivax Content Had Mixed Results

 While Facebook's policy on removing repeat offenders who post COVID-19 vaccine misinformation may have reduced the number of posts in anti-vaccine pages/groups, it has not led to a sustained reduction in engagement with anti-vaccine content, a study suggested.

Explicitly anti-vaccine pages and groups were 2.13 times (95% CI 1.70-2.66) more likely to be removed than their pro-vaccine counterparts, and anti-vaccine post volumes decreased 1.47 times more than pro-vaccine post volumes (RR 0.68, 95% CI 0.61-0.76), reported David A. Broniatowski, PhD, of George Washington University in Washington, D.C., and colleagues in Science Advancesopens in a new tab or window.

Posts to anti-vaccine groups also decreased relative to pre-policy trends, and anti-vaccine group post volumes decreased 3.57 times more than pro-vaccine group post volumes (RR 0.28, 95% CI 0.21-0.37).

The authors pointed out that pro-vaccine content was also removed, "and anti-vaccine content became more misinformative, more politically polarized, and more likely to be seen in users' newsfeeds."

Co-author Lorien C. Abroms, ScD, MA, also of George Washington University, told MedPage Today that platforms like Facebook enacting policies on vaccine misinformation "could potentially have a big public health impact."

When Facebook announced this policy in late 2020, Abroms noted that "we thought this was a wonderful opportunity to evaluate: could they rein in their misinformation as they intended to do?"

She said that they "saw that while the sheer number of posts went down, engagement with misinformation not only rebounded but went to a level that was higher than its engagement level prior to the policy announcement."

Post-policy, there were no significant changes in engagement with content on anti-vaccine pages (RR 0.73, 95% CI 0.28-1.90). In fact, anti-vaccine Facebook groups grew in engagement, being on average 33% higher than what would be expected on the basis of pre-policy trends (RR 1.33, 95% CI 1.05-1.69), although this increase was not significant when compared with pro-vaccine group trends (RR 1.22, 95% CI 0.94-1.56).

Of the misinformative posts, the largest increase were in those alleging severe adverse reactions to the COVID-19 vaccine (OR 1.41, 95% CI 1.05-1.90). Reports of hospitalizations and deaths (OR 1.23, 95% CI 1.09-1.38) also increased, as did posts promoting alternative medicine (OR 1.32, 95% CI 1.28-1.35).

Posts about alleged negative effects of vaccines on immunity, either due to toxic ingredients (OR 1.24, 95% CI 1.13-1.37), or focused on children (OR 1.34, 95% CI 1.02-1.77), also increased.

There were also increases in posts about schools (OR 2.02, 95% CI 1.65-2.46), other vaccine mandates (OR 1.21, 95% CI 1.16-1.27), legislation opposing vaccination (OR 1.06, 95% CI 1.02-1.13), and anti-vaccine medical advice (OR 1.14, 95% CI 1.09-1.18).

Ultimately, Broniatowski and team concluded that "since engagement levels with anti-vaccine page content did not differ significantly from pre-policy trends, this potentially reflects vaccine-hesitant users' desire for more information regarding a novel vaccine at a time when specific false claims had not yet been explicitly debunked."

Regina Royan, MD, of the University of Michigan in Ann Arbor, told MedPage Today that this study's findings illuminate "just how much work still needs to be done, and the increasingly polarized climate in which physicians and public health scientists are trying to work."

Because the study only looked at posts in English, Royan noted that the research wasn't able to capture changing vaccine messaging among other groups.

"There is some evidence that policies and tools designed to identify misinformation are even worse at identifying misinformation in Spanish," she said, adding that future research should analyze the effectiveness of similar policies in posts from other languages.

"Misinformation kills, and there will be more pandemics in our lifetime," Royan noted. "Figuring out how to accurately identify misinformation and prevent its spread is imperative to prevent loss of life during this pandemic and the next."

For this study, Broniatowski and colleagues used CrowdTangle to pull data from public Facebook pages and groups. In December 2020, the social media giant announced it would remove accounts and pages that repeatedly post misinformation about COVID-19 vaccines, which was later extended to vaccine misinformation in general.

The researchers said that they analyzed both pages and groups because they serve different functions: "Only page administrators may post in pages, which are designed for marketing and brand promotion. In contrast, any member may post in groups, which serve as a forum for members to build community and discuss shared interests," they wrote.

The pre-policy search came up with 216 vaccine-related pages (114 anti-vaccine and 102 pro-vaccine) as well as 100 groups (92 anti-vaccine and 8 pro-vaccine); within those were 119,091 posts to pages (73% anti-vaccine) and 168,419 posts to groups (97% anti-vaccine) that were created from Nov. 15, 2019 to Nov. 15, 2020.

There were 177,615 posts to those same pages (62% anti-vaccine) and 244,981 posts to those same groups (95% anti-vaccine) that were created from Nov. 16, 2020 to Feb. 28, 2022. Five percent of public anti-vaccine groups switched to private, which evaded CrowdTangle.

The authors noted several limitations to their study, including that they could only analyze public Facebook pages and groups and therefore their results do not apply to private ones. Additionally, it's possible that CrowdTangle missed some data, particularly from pro-vaccine spaces. Lastly, the tool cannot distinguish between individuals versus page administrators posting.

Disclosures

The study was funded in part by the John S. and James L. Knight Foundation through the GW Institute for Data, Democracy, and Politics and grants from the National Science Foundation.

Broniatowski reported receiving consulting fees from Merck & Co. and a speaking honorarium from the United Nations Shot@Life Foundation.

Abroms and other co-authors had no competing interests to disclose.

Royan also had no conflicts of interest.

Primary Source

Science Advances

Source Reference: opens in a new tab or windowBroniatowski DA, et al "The efficacy of Facebook's vaccine misinformation policies and architecture during the COVID-19 pandemic" Sci Adv 2023; DOI: 10.1126/sciadv.adh2132.

https://www.medpagetoday.com/special-reports/features/106367

Weight-Loss Surgery Tied to Lower Blood Cancer Risk in Women

 Bariatric surgery for obesity was associated with a reduced risk of hematologic cancers in a prospective Swedish study spanning more than three decades.

In individuals treated for obesity from 1987 to 2001, bariatric surgery was linked with a 36% lower risk of developing a hematologic cancer over subsequent decades compared with usual care (adjusted hazard ratio [aHR] 0.64, 95% CI 0.41-0.99, P=0.04), reported Magdalena Taube, PhD, of the University of Gothenburg in Sweden, and colleagues.

Of note, the association was only seen among women (HR 0.47, 95% CI 0.27-0.79), they detailed in Lancet Healthy Longevity

opens in a new tab or window.

"Our results suggest that obesity is a modifiable risk factor for hematological cancer and that bariatric surgery might reduce the risk of hematological cancer in women with obesity," Taube and colleagues wrote. "Healthcare providers and policy makers working in the field of cancer prevention should consider bariatric surgery a primary prevention resource for people with obesity."

The researchers also observed lower risks for lymphoma specifically (aHR 0.49, 95% CI 0.25-0.96) and death due to hematological cancer (aHR 0.29, 95% CI 0.09-0.94) associated with bariatric surgery.

In a commentary accompanying the studyopens in a new tab or window, Sonja Chiappetta, MD, and Vincenzo Bottino, MD, both of the Ospedale Evangelico Betania in Naples, Italy, emphasized that bariatric surgery should provide support for a change in lifestyle.

"Therefore, the role of nutrition, nutrigenomics, and fasting should also be highlighted when discussing obesity-associated cancer and cancer prevention," they wrote, adding that more biological and clinical studies looking at the role of food and calorie restriction and nutrigenomics are needed in order to "complement the global fight against the obesity epidemic and its associated diseases, especially cancer."

For their study, Taube's team looked at 4,047 adult participants (37 to 60 years) from the Swedish Obese Subjects cohort, which was designed to compare morbidity and mortality between individuals with obesity who underwent bariatric surgery (n=2,007) and a matched group of controls (n=2,040) receiving usual obesity care.

Average age of participants was about 48 years, and 71% were women. Participants were followed for up to 33 years at study cutoff (median 24.4 years in the surgery group and 22.7 years in the control group).

During follow-up, a total of 85 hematologic cancers were detected (34 in the surgery group and 51 in the usual-care group), nearly half of which were lymphomas. A total of 16 deaths from blood cancers occurred (three and 13 in the two groups, respectively).

Mean weight loss in the surgery group was 28.5 kg at the 2-year follow-up visit and sustained over time -- 20.8 kg at the 10-year follow-up visit, and 21.2 kg at the 15-year follow-up visit. In the control group, mean weight changes never exceeded a gain or loss of 3 kg.

One of the study limitations is that most patients in the surgery group underwent either vertical banded gastroplasty (68%) or banding (19%), procedures rarely used today, noted Taube and co-authors.

"However, convincing data show that the association between bariatric surgery and cancer risk depends on the magnitude of weight loss, and it should be noted that the magnitude of weight loss after vertical banded gastroplasty is similar to that after laparoscopic sleeve gastrectomy," they wrote.

Disclosures

Study funding came from various sources, including the Swedish Research Council, the Health & Medical Care Committee of the Region Västra Götaland, the Swedish Heart Lung Foundation, Gothenburg Medical Society, and the Adlerbert Research Foundation.

Taube had no disclosures. One co-author reported employment with AstraZeneca.

Editorialists Chiappetta and Bottino had no disclosures.

Primary Source

The Lancet Healthy Longevity

Source Reference: opens in a new tab or windowSjöholm K, et al "Long-term incidence of haematological cancer after bariatric surgery or usual care in the Swedish Obese Subjects study: a prospective cohort study" Lancet Healthy Longev 2023; DOI: 10.1016/ S2666-7568(23)00141-1

Secondary Source

The Lancet Healthy Longevity

Source Reference: opens in a new tab or windowChiappetta S, Bottino V "Obesity-associated cancer prevention" Lancet Healthy Longev 2023; DOI: 10.1016/S2666-7568(23)00176-9

https://www.medpagetoday.com/hematologyoncology/hematology/106370

FDA Reviewers Have Concerns About Artificial Womb Trials in Humans

 FDA staff raised concerns that need to be addressed prior to potential human tests of artificial womb technology (AWT), a device that simulates a womb for extremely premature infants, as detailed in briefing documents

opens in a new tab or window released ahead of a Pediatric Advisory Committee meetingopens in a new tab or window next week.

AWT devices are intended to treat extremely premature infants, who have increased risks of mortality and morbidity -- especially those born at less than 28 weeks' gestation. The current standard of care involves treatments related to respiratory care, cardiovascular support, thermoregulation, nutrition, and neurodevelopmental impairment in the neonatal intensive care unit (NICU).

"The goal of AWT is to provide a bridge from extreme preterm birth to later gestation within a physiologic environment that mimics the womb in order to reduce prematurity-associated morbidity associated with standard NICU care," FDA staff wrote in the briefing documents.

Noting the "challenges in assessing the benefit-risk profile of this type of highly innovative technology, and the complexities related to the vulnerable neonatal population," FDA reviewers have asked the committee to discuss four major points on September 19 and 20. First, the strengths and weaknesses of large animal models and what additional data are needed to inform the proof of concept. Next, they are being asked to consider gaps in knowledge that could be answered with nonclinical studies. They're also going to consider whether the existing data are enough to support first-in-human studies and what guidelines would need to be followed for patient safety. Lastly, the panel will discuss how to obtain informed consent in an AWT trial and what challenges may arise in doing so.

Several large animal models have already assessed AWT. The University of Michigan in Ann Arbor, Tohoku University in Japan, the University of Western Australia, and Children's Hospital of Philadelphia have all done studies using lambs, and the University of Toronto used miniature pigs in a previous study.

Because AWT inherently involves neonatal patients, the FDA reviewers pointed out there are additional ethical considerations. For instance, a trial must have minimal risk and the investigational device must "offer a prospect of direct clinical benefit to the child, the risk must be justified by the anticipated benefit, and the anticipated benefit-risk profile must be at least as favorable as that presented by accepted alternative treatments," they wrote.

Therefore, there must be adequate data that show AWT would have benefits "at least as favorable as" the standard of care provided in the NICU before a first-in-human trial could begin.

FDA staff also detailed necessary components of a first-in-human study design. For instance, the AWT study should include "a robust plan for safety monitoring and adverse event reporting, pre-established individual and study stopping rules, oversight by an independent Data and Safety Monitoring Board (DSMB), endpoints to evaluate for a clinically meaningful treatment effect, and an effective informed consent process."

In sum, a clinical development program for an AWT device should provide evidence that using AWT would "support normal growth and organ maturation, while reducing high rates of prematurity-associated morbidities observed with current NICU standard of care, in infants born extremely premature," the reviewers wrote.

While the FDA is not required to follow the recommendations of its advisory committees, it typically does.

https://www.medpagetoday.com/publichealthpolicy/fdageneral/106372

Cell Transplant Boosts Lung Function in COPD Patients

 Research presented at this year's annual European Respiratory Society

opens in a new tab or window congress included early successes in transplanting a patient's own lung cells to ease chronic obstructive pulmonary disease (COPD), idrevloride treatment for primary ciliary dyskinesia, and using ultrasounds as a guide for more comprehensive pulmonary embolism screening.

Improved Gas Exchange Capacity in COPD Through Lung Cell Transplants

Autologous P63+ lung progenitor cell transplantation could help improve lung function for COPD patients, a phase I trial suggested.

After cell transplants, median diffusing capacity of the lungs for carbon monoxide increased from 30% to 39.7% after 12 weeks, then up to 40.3% after 24 weeks. Two patients who were previously experiencing mild emphysema also saw resolved symptoms after 24 weeks, which was confirmed though CT. Emphysema patients with more severe symptoms saw mild improvements.

"The intrapulmonary administration of cells is feasible and safe, and points to significant improvements in lung diffusion capacity after cell therapy," said Wei Zuo, PhD, of Tongji University in Shanghai. "Mild emphysema, which was previously considered permanent, can be repaired by cell transplantation."

Zuo explained that in this process, currently existing P63+ progenitor cells were extracted from COPD patients via bronchoscopic brush, cloned, then transplanted back into the donor patient through bronchoscopic injection. Patients received close medical monitoring for 24 weeks. Single doses of cloned progenitor cells consisted of approximately 0.6~5.2×10⁶ cells for every kg of the patient's body weight.

The first-in-human study included 20 COPD patients, with three patients acting as a control group.

No grade ≥3 adverse events occurred in patients, while 47.1% of transplant patients and 33.3% of control patients experienced grade 1 events. Grade 2 adverse events were seen in 5.9% of treatment patients and 33.3% of control patients.

The average patient St. George's Respiratory Questionnaire scores improved in 58.8% of the transplant group and 33.3% of the control group. Median 6-minute walk test results improved in two-thirds of treatment patients, while patients in the control group only saw maintenance or decreases in their scores. Forced expiratory volume in the first second (FEV₁) improved in 23.5% of treatment patients, while control patients saw no improvement.

A phase II trial of the transplantation treatment is currently approved for COPD, as is a phase I/II trial in idiopathic pulmonary fibrosis.

Idrevloride for Primary Ciliary Dyskinesia

Inhaling idrevloride for about 4 weeks led to significant improvements of lung function in primary ciliary dyskinesia (PCD) when compared to just hypertonic saline alone, the CLEAN-PCD study found.

After 28 days using idrevloride in hypotensive saline, percent predicted FEV₁ (ppFEV₁) improved 1.5% more than with hypotensive saline solution alone (P=0.044). This was also true when treatment was extended for 56 days. Findings from the phase II study were also recently published in Lancet Respiratory Medicine

opens in a new tab or window.

Presenter Thomas Ferkol, Jr., MD, of the University of North Carolina at Chapel Hill, said the idrevloride therapy will be studied as part of an upcoming year-long phase III study in PCD.

PCD is a rare genetic disorder, estimated to impact one person per 7,500 worldwide. Patients with PCD experience impairments of motile ciliary function, which can present itself in a wide array of symptoms ranging from chronic respiratory tract disease to subfertility.

Ferkol noted that studies on the disorder are far and few between, with only two previously published randomized controlled trials on the subject.

"Over 50 genes have been linked with primary ciliary dyskinesia, and at current, there is no specific therapy for this disease. In fact, most of the therapies we use have been borrowed from other diseases like cystic fibrosis and asthma," he added.

Ultrasound as Gatekeeper to Imaging for Pulmonary Embolism

Utilizing ultrasounds could drastically cut down on the number of referrals to diagnostic imaging for pulmonary embolism (PE), but more work is needed to reduce false negatives.

In the ultrasound group of a randomized trial, PE was considered confirmed in patients who exhibited visible proximal deep venous or ventricular thrombus, two or more subpleural infarctions, and/or McConnell's sign or D-sign. PE was dismissed if patients didn't appear to have those signs, had an obvious differential diagnosis thanks to the ultrasound, and if PE was not considered a likely diagnosis.

Patients were only sent on for further imaging when they met neither set of criteria, resulting in referrals to such diagnostic imaging falling by 45.2% with the ultrasound strategy. PE was diagnosed in 20 out of 40 people who underwent diagnostic imaging in this group, with another three diagnosed through discovery of deep venous thrombosis.

However, ultrasound carried a 6.7% failure rate, as two out of 30 people turned out to have PE after having it dismissed initially, reported Casper Falster, MD, a PhD candidate at the Odense Respiratory Research Unit in Denmark, who stressed the possibility of failure with ultrasound as a detection method.

"It is very important to consider that if I wanted to reduce referral by half, I could just flip a coin," he said.

Falster stated that while D-dimer is an existing test that can help diagnose PE, it gets less specific with patient age and comorbidity.

Disclosures

The COPD study was sponsored by Regend Therapeutics, and Zuo reported a relationship with the study funder.

CLEAN-PCD was supported by the NIH, the Cystic Fibrosis Foundation, ReCode Therapeutics, and Parion Sciences/Vertex Pharmaceuticals, which funded the study. Ferkol reported relationships with the Cystic Fibrosis Foundation, Translate Bio, and Arrowhead Pharmaceuticals.

Falster reported relationships with AstraZeneca and Bristol Meyers Squibb.

Primary Source

European Respiratory Society

Source Reference: opens in a new tab or windowWang Y, et al "Autologous transplantation of P63+ lung progenitor cells for chronic obstructive pulmonary disease therapy" ERS 2023.

Secondary Source

European Respiratory Society

Source Reference: opens in a new tab or windowFalster C, et al "Does ultrasound in suspected pulmonary embolism safely reduce referral to diagnostic imaging? – a randomized controlled trial" ERS 2023.

Additional Source

European Respiratory Society

Source Reference: opens in a new tab or windowRingshausen F, et al "Safety and efficacy of idrevloride in people with primary ciliary dyskinesia: a double-blind, randomized, placebo-controlled crossover trial (CLEAN-PCD)" ERS 2023.

https://www.medpagetoday.com/meetingcoverage/ers/106373

"Not A Good Decision For Young People" - Fla. Surgeon-General Snubs FDA 'COVID Boosters-For-All' Guide

 Uttering words that would have seen you excommunicated from 'good' society, ostracized to an island of racists, bigots, and vaccine-deniers; Florida Surgeon General Dr. Joseph Ladapo said in a statement that the vaccines "are not backed by clinical evidence, but blind faith alone with ZERO regard for widespread immunity."

In guidance (pdf) to patients and doctors, the Florida Department of Health added:

Based on the high rate of global immunity and currently available data, the state surgeon general recommends against the COVID-19 booster for individuals under 65. Individuals 65 and older should discuss this information with their health care provider, including potential concerns outlined in this guidance."

This directly contradicts guidance from The White House (everyone get up to date) and the CDC and FDA (endorsing the new jabs for anyone over 6 months old):

“We continue to live in a world where the CDC and the [Food and Drug Administration], when it comes to COVID at least, are just beating their own path in a direction that’s inexplicable in terms of thinking about data and in thinking about common sense,” Ladapo said.

And three years into this flu season, Ladalpo highlights 'herd immunity' among most of America:

“With the amount of immunity that’s in the community - with virtually every walking human being having some degree of immunity, and with the questions we have about safety and about effectiveness, especially about safety, my judgment is that it’s not a good decision for young people and for people who are not at high risk at this point in the pandemic,” he said.

Florida Governor DeSantis agreed:

“I will not stand by and let the FDA and CDC use healthy Floridians as guinea pigs for new booster shots that have not been proven to be safe or effective,”

In March, the CDC and FDA sent a letter to Ladapo, warning that he was fueling vaccine hesitancy and harming Florida’s seniors. 

Ladalpo is not alone in his scepticism.

"Pushing a new COVID vaccine without human-outcomes data makes a mockery of the scientific method and our regulatory process," Drs. Marty Makary and Tracy Beth Hoeg said in an op-ed.

"If public-health officials don’t want a repeat disappointing turnout of Americans who get the COVID booster shot, they should require a proper clinical trial to show the American people the benefit," they added.

Just 17 percent of Americans received one of the bivalent doses, which were made available in the fall of 2022. The new vaccines replaced the bivalents.

"The CDC is advising the children get these boosters when there's no evidence that children receive any benefit and clear evidence that they receive harm," Dr. Robert Malone, who helped invent the messenger RNA (mRNA) technology the Pfizer and Moderna vaccines use, said on EpochTV's "Crossroads."

Risks include myocarditis, a form of heart inflammation that can lead to sudden death.

And cue the mainstream media 'blood on their hands... science-denying' headlines.

https://www.zerohedge.com/medical/not-good-decision-young-people-florida-surgeon-general-snubs-fda-covid-boosters-all